Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
NCT ID: NCT00578708
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2003-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
AMPLATZER Membranous VSD Occluder
Device closure with the AMPLATZER Membranous VSD Occluder
Interventions
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AMPLATZER Membranous VSD Occluder
Device closure with the AMPLATZER Membranous VSD Occluder
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Supracristal ventricular septal defects
* Left ventricle to right atrium shunting
* Prolapse of the aortic valve
* Right to left shunting through the defect
* Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
* Patients with \<2mm aortic rim
* Sepsis (local/generalized)
* Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
* Patients who are ASA intolerant
* Unable to be followed for the duration of the clinical trial
* Inability to obtain informed consent
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Children's Hospital UN/CU)
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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G020202
Identifier Type: -
Identifier Source: secondary_id
AGA-008
Identifier Type: -
Identifier Source: org_study_id
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